Kornimate/medical-research-clean huggingface dataset:
mobility assessment & follow-up in frail elderly: clinic-technical validation of a smart insole in real life

Conditions: Fragility

Summary: the investigators aim is to evaluate an instrument for supporting physical activity and monitors multiple parameters of frailty (a pre-disability condition) in frail elderly persons. the investigators are therefore developing a smart shoe insole to monitor key parameters of frailty during subject daily life and to promote walking. our primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients at home. results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to prevent disability.

the object of the present project is to promote the prevention of disability by providing 1) a feed-back and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. the device consists of a smart, removable insole. it measures dynamic characteristics of gait (e.g., speed, variability, distance) as well as body weight modifications with minimal invasiveness. the insole transmits wireless the collected data to a storage server through a touchpad. data will then be available for at distance consultations by users (i.e., patients or physicians). the investigators will conduct a wide range of evaluations of the device (technical, clinical, social, ergonomic, and economic), which will allow the optimization of the prototype. the evaluation of the prototypes will preliminary takes place at the blagnac smart house. 10 healthy volunteers will test the device. the second evaluation phase will involve 60 frail community-dwelling subjects, with 30 of them which will use the smart insoles for 3 months. comprehensive assessments will be conducted to highlight the feasibility, acceptability, interoperability, integration in healthcare network, and clinical relevance of the technological device in comparison to usual care.

Eligibility criteria:
inclusion criteria: * patient aged 65 or more, living at home; * presenting a frailty syndrome for the second phase, and robust volunteers for the first phase; * informed and written consent by the patient or the legal representative or the reliable person when appropriate. exclusion criteria: * no access to adsl; * patient's life expectancy less than 12 months; * patient presenting disability with an activity of daily living score \< 4/6 and/or a mini mental state \<24/30; * non agreement of study participation of patients or legal representative or the reliable person when appropriate.

Keywords: elderly robust volunteers for the first phase; tele-monitoring self-management patient 65 and over presenting a frailty syndrome for the second phase
study of rituximab plus high-dose chemotherapy poor prognosis non-hodgkin's lymphoma

Conditions: Lymphoma, Non-Hodgkin's

Summary: this study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, stem cell support and rituximab (which is a form of immunotherapy).

combination chemotherapy is the standard treatment as initial therapy for aggressive nhl. standard chemotherapy cures less than 40% of patients. high-dose chemotherapy with stem cell support (or transplant) is showing some positive results in patients with nhl that fail standard chemotherapy. the cure rate of this treatment is only about 50%. another treatment option called immunotherapy is being tested in lymphoma patients to see if adding immunotherapy to nhl treatments improves results. rituximab, a form of immunotherapy, is an antibody (a type of protein) that attacks the cd20 protein found on lymphoma cell, which may result in the death of the lymphoma cell. the study design is as follows: patients with poor prognosis nhl receive rituximab as part of the peripheral blood progenitor cell mobilization process and as part of the preparative regimen in combination with high-dose chemotherapy. granulocyte colony-stimulating factor (g-csf) mobilized peripheral blood progenitor cells (pbpc) are collected and stored. after recovery from high-dose cyclophosphamide, patients are admitted to the hospital for transplant. the preparative regimen consists of rituximab, followed by high-dose chemotherapy.

Eligibility criteria:
inclusion criteria: * histologically documented, aggressive and/or intermediate grade and high-grade b cell nhl, cd20 positive. * histologic subtypes include follicular large cell, diffuse small cleaved cell, diffuse mixed small and large cell, diffuse large cell, anaplastic large cell, and mantle cell lymphomas. * nhl must have high-intermediate or high international prognostic index (standard ipi) score at diagnosis. mantle cell nhl is eligible regardless of ipi score. * complete or partial response to first-line therapy. * treated cns or meningeal disease, using radiation therapy and/or intrathecal chemotherapy, is allowed. patients with meningeal disease must have cytologically negative csf at time of study entry. * cumulative total doxorubicin: \<500 mg/m2 * performance score 0-2 * patients with a prior malignancy are eligible if they were treated with curative intent and have no evidence of active disease. * patients must not be pregnant or nursing. * informed consent exclusion criteria: * pregnant or nursing
adalimumab in adult japanese subjects with psoriasis

Conditions: Psoriasis

Summary: to evaluate efficacy, safety, and pharmacokinetics of adalimumab in japanese participants with psoriasis

this was a continuation trial of adalimumab in participants with moderate to severe chronic plaque psoriasis who had completed study m04-688 (nct00338754), a 24-week, double-blind, placebo-controlled study. this study was an open-label extension study that continued until the approval of adalimumab for the treatment of psoriasis in japan. during study m04-688 (nct00338754), participants received 24 weeks of treatment with adalimumab 40 mg every other week (eow) with or without a loading dose, adalimumab 80 mg eow, or placebo. at the start of this study, participants who had received adalimumab 40 mg eow or adalimumab 80 mg eow in study m04-688 (nct00338754) continued on the same treatment regimen. participants who had received placebo during study m04-688 (nct00338754) were re-randomized at the start of this study to receive adalimumab 40 mg eow or adalimumab 80 mg eow. participants in the adalimumab 40 mg eow treatment group who failed to achieve a pasi50 response (\>= 50% reduction in the psoriasis area and severity index score from baseline of study m04-688 \[nct00338754\]) at or anytime after week 12 of this study were given the option to increase their dose to adalimumab 80 mg eow. once the dose was escalated, there was no option to de-escalate dosing back to 40 mg eow. participants who failed to achieve pasi50 responses while receiving adalimumab 80 mg eow may have been discontinued from the study after evaluating the risk/benefit of further treatment with adalimumab. at week 28 of this study, it was mandatory for all participants who started the study in the adalimumab 80 mg eow treatment group (i.e., not including the dose escalators described above) to reduce their dose to adalimumab 40 mg eow, regardless of their response status. following this mandatory dose reduction, if these participants failed to achieve or maintain pasi50 response, they were permitted to escalate their dose to adalimumab 80 mg eow. there was no option to de-escalate dosing back to 40 mg eow following dose escalation. data in this clinical trial results disclosure are analyzed as observed according to treatment received at the start of this study (i.e., adalimumab 40 mg eow or adalimumab 80 mg eow) regardless of subsequent dose escalation. data are summarized according to participants' cumulative exposure to adalimumab in study m04-688 (nct00338754) and this study.

Eligibility criteria:
inclusion criteria: - participants who completed study m04-688 (nct00338754) exclusion criteria: - participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study

Keywords: psoriasis
effects of rosuvastatin on aortic stenosis progression

Conditions: Aortic Stenosis

Summary: the purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis. patients must have a diagnosis of mild to moderate aortic stenosis (as) and no clinical indication for the use of cholesterol lowering agents. a multi-centre, randomized, double-blind, placebo-controlled study, with a two year recruitment period, and a treatment duration of a minimum of 3 years from the time of the last patient randomized to a maximum of 5 years.


Eligibility criteria:
inclusion criteria: * mild to moderate as defined by peak doppler aortic valve velocity 2.5 to 4 m/sec * baseline ldl-c value must be within targeted level for all risk categories according to the canadian guidelines * baseline triglyceride levels must be within target level for the risk categories exclusion criteria: * very mild as defined by peak doppler as velocity \<2.5m/sec, because the rate of progression is not well defined; females of child bearing potential who do not practice adequate contraception. * severe as defined by peak doppler as velocity \> 4m/sec. these patients are excluded because they will have a high probability of aortic valve replacement even without further as progression. * greater than moderate aortic regurgitation, defined as aortic jet width to aortic outflow tract ratio \>0.45; patients with diabetes or with a fasting blood sugar level \> 7.0 mmol/l (must be confirmed with one repeat assay within 14 days). * significant concomitant mitral valve disease, defined by \> moderate mitral regurgitation (mr) or mitral valve area (mva)\ 30%), according to the canadian guidelines.

Keywords: progression of aortic stenosis
risk scoring model for endometrial cancer

Conditions: Oncology

Summary: a prospective cohort study to assess rhea ( recurrent vaginal bleeding, hypertension, endometrial thickness and age) scoring model for prediction of endometrial carcinoma


Eligibility criteria:
inclusion criteria: - all postmenopausalwomen with vaginal bleeding and endometrial thickness more than 4 mm exclusion criteria: * all patients with vaginal bleeding arising from cervical or vaginal or vulval disease or due to hormonal replacement therapy (scheduled bleeding).
efficacy of repetitive transcranial magnetic stimulation (rtms) as an add-on treatment for resistant ocd

Conditions: Obsessive-Compulsive Disorder

Summary: ocd is a chronic condition with a high rate of poor responders to conventional treatments, such as antidepressants and psychotherapy. chronic symptoms can lead to important social impairment and suffering for patients and families. the present study aims to investigate if the addition of transcranial magnetic stimulation can provide enhanced response to conventional treatment. transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.

the treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 6 consecutive weeks. each session lasts up to 30 minutes. side effects include scalp discomfort and mild headache. no anesthesia is required. stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results. the present technique has never been employed in previous studies, but risks are insignificant

Eligibility criteria:
inclusion criteria: * resistant ocd patients: maximum 25% reduction in yale-brown obsessive-compulsive scale (y-bocs) scores after at least 3 adequate trials with serotonin reuptake inhibitors (sri) (including clomipramine) and 20 hours of cognitive behavioral therapy (cbt) or documented intolerance to either treatment. exclusion criteria: * metallic cerebral implants * history of severe trauma or brain injury * organic brain disease * severe somatic disease * history of drug dependence * chronic psychosis * present manic state

Keywords: obsessive-compulsive disorder rtms transcranial magnetic stimulation treatment randomized controlled trials
twitter and diabetes

Conditions: Diabetes; Cardiovascular Disease

Summary: twitter use is surprisingly well represented across broad demographic population segments and health-related messages. the promise of using twitter is that its use is growing rapidly, it allows the investigators to view communications that were impossible to intercept before, and it potentially provides information faster and less expensively than collection from other media channels. prior work also supports that social media interventions can improve health behavior change (e.g. weight loss, physical activity) and outcomes.the overarching goals of this proposal are to understand the uses and limitations of this communication channel to improve patients' ability to manage their cv health condition.

use twitter to deliver high impact cv health related content to improve patient activation and disease management for diabetes.

Eligibility criteria:
inclusion criteria: * diabetes * uses social media exclusion criteria: * \<21 years of age * pregnant

Keywords: diabetes social media
bip foley in prevention of cauti at rehab station

Conditions: Complications; Catheter, Urinary Infection or Inflammation

Summary: this is a prospective, cross-over, randomized, controlled, partly blinded study evaluating safety and performance of noble metal alloy urinary catheters (bip foley, bactiguard ab) of both latex and silicone. the included patients are permanently catheterized spinal cord injured patients at the spinalis clinic at rehab station in stockholm, sweden. primary outcome measures: • the primary objective is to evaluate the efficacy of long term suprapubic use of bip foley catheters, compared to the use of standard catheters for the same time period, on re-current symptomatic catheter associated urinary tract infection (cautis). secondary outcome measures: • to evaluate safety/performance of the catheter, i.e. antibiotic use, bacteriuria, bacteremia, urosepsis and icu stay. exploratory outcome measures: • assessment of levels of immunological markers in urine, urinary bacterial type and resistance pattern, catheter comfort, stability of the coating, and bacterial biofilm on the catheter surface after use.


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) * patients with permanent suprapubic urethral catheter (foley catheter) of latex or silicone * at least 3 documented cauti infections during last year * spinal cord injured, changing catheters at rehab station every 10 weeks (+/- 2 weeks) exclusion criteria: * children (˂18 years) * participating in other clinical trial(s) with exposure/treatment that could affect the outcome of the present study * stones (calculi) in the urinary tract (these patients can be included after the stones have been removed) * patients on antibiotic treatment (these patients can be included after the treatment is completed (+10 days of expectance))
evaluation of new or worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab for bone loss

Conditions: Cancer; Cataract; Low Bone Mineral Density; Osteopenia; Osteoporosis; Prostate Cancer

Summary: this is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation therapy.


Eligibility criteria:
inclusion criteria: * men ≥ 30 years of age with non-metastatic prostate cancer, having undergone bilateral orchiectomy or initiated androgen deprivation therapy (adt) with gonadotropin-releasing hormone (gnrh) agonists and is expected to continue on adt for at least 12 months * adequate visual accuracy allowing eye testing * bone mineral density (bmd) requirements: osteopenia if under 70 years of age; osteopenia or normal bmd if over 70 years of age * signed informed consent exclusion criteria: * previous surgery for cataracts in both eyes, current diagnosis of cataracts, cataracts surgery foreseen in the near future, or ocular disease leading to visual loss * diagnosis of osteoporosis

Keywords: lens opacification bone loss androgen deprivation therapy non-metastatic prostate cancer
nextgen - clinical implication of next generation sequencing

Conditions: Urinary Tract Infections

Summary: recently more advanced techniques, including polymerase chain reaction (pcr) and next generation sequencing (ngs) are available to detect bacteria in urine based on bacterial genomes. comparing to traditional culture, these techniques have more sensitivity and could potentially be of a great help in patients with colony count of less than 10,000 and more than zero.

bacterial sensitivity test for different antibiotics are the most important guide for treatment of patients with uti. unfortunately, for patients with less than 10,000 colony count (cc), usually no sensitivity test is done and there is not any guide for appropriate antibiotic therapy for this group.

Eligibility criteria:
inclusion criteria: * female at least 18 years of age * u/c (urinary culture) growth of \<10,000 colony-forming units (cfu) * understanding and acceptance of the need to return for all scheduled follow-up visits * able to give informed consent exclusion criteria: * catheter in use (foley or suprapubic or intermittent) * not able to provide clean midstream urine * antibiotic consumption in the past 2 weeks before signing the consent * pregnant or planning to conceive * incarcerated
virtual psychiatric care for perinatal depression

Conditions: Perinatal Depression

Summary: perinatal depression occurs in 15% of pregnant women and new mothers, yet as few as 1 in 5 receive adequate treatment. it has a negative impact on the woman herself, as well as a potential for serious consequences for her child. virtual psychiatric care is a potential model that may provide accessible mental health care during this time, as barriers to in-person care often include unpredictable infant schedules, competing childcare demands, or travel/cost challenges. the virtual-pnd intervention consists of 12-weeks of the option of supplementing in-person psychiatric care with secure, in-home real-time video-visits through the ontario telemedicine network. this pilot rct will demonstrate the feasibility of proceeding to a future large-scale rct evaluation of virtual psychiatric care for this population.

this is a two-site pilot randomized controlled trial (rct) to evaluate the feasibility of a virtual psychiatric care for perinatal depression (virtual-pnd) intervention protocol, comparing virtual care to in-person care only. participants will be pregnant or postpartum women with a major depressive disorder who are referred for care at one of the participating study sites. each study site is a specialist reproductive psychiatric program where women from the greater toronto area are referred, and generally treated with in-person care. those randomized to the virtual care group will be able to receive psychiatric visits with video-based visits. those randomized to the in-person care group will receive in-person care only, as per usual clinical practice at the study sites. the length of the active treatment phase will be 12 weeks from enrolment. the overall objective of this pilot rct is to determine the feasibility of conducting a larger rct to evaluate the efficacy of the treatment model, comparing outcomes among those with and without access to virtual care, and cost-effectiveness.

Eligibility criteria:
inclusion criteria: * ≥18 years old * pregnant or 0-12 months postpartum * experiencing clinically significant depressive symptoms (defined as a score of ≥12 on the edinburgh postnatal depressive scale, epds, during eligibility screening) * able to access the internet on a device (i.e. mobile phone, tablet, personal computer) with video-visit capacity (including web camera and speakers) * comfortable with email communication exclusion criteria: * active alcohol/substance use disorder in the past 12 months * active suicidal ideation * current mania or psychosis * unsuitable for virtual care, as per assessment of the treating psychiatrist
survey of blood transfusion practices in critically ill patients at high altitude

Conditions: Anemia; Critically Ill

Summary: the purpose of this study is to describe current practice on red blood cell transfusion in critically ill patients of intensive care units located in high altitude areas

anemia has been identified as a common complication in the critically ill patient. approximately 40 and 60% are transfused in normal clinical practice. however transfusions are not free of adverse events including: transfusion-associated lung injury, infectious complications, progression of organ failure, fluid overload associated with transfusion, among others. therefore, several clinical trials have been designed to define red blood cell transfusion thresholds. mainly two groups have been compared: 1) liberal schemes in which patients are transfused with higher levels of hemoglobin (generally ≤ 10 g / dl) and restrictive regimens with lower levels (≤ 7 g / dl). institutions such as the british committee for standards in hematology have developed recommendations in favor of restrictive strategies based mainly on the tricc (transfusion requirements in critical care) study conducted by hebert et al. on the other hand, it is well known that as consequences of living in places at high altitude physiological modifications occur in the human. one of these adaptations is the increase in hemoglobin levels occurring in people living at high altitude, especially in andean residents, in whom the hypoxia promotes an increase in the production of red blood cells. the recommendation of the restrictive strategy in the transfusion of red blood cells has been adopted in several countries with numerous populations living at high altitudes, although this practice has not been evaluated in these patients. the purpose of this study is to describe the current practice on transfusion of red blood cells in critical patients treated in intensive care units located in high altitude areas (over 1500 m) to determine whether physicians follow the recommendations of restrictive strategies. this is an observational, non-randomized, cross-sectional survey performed with intensivists of bolivia, colombia, ecuador, méxico and perú. the data will be collected from an on-line scenaries based survey. the survey is designated to assessed the effect of severity, need of surgery, severe hypoxia, and alteration in tisular perfusion as modifiers of transfusion thresholds. besides unit characteristics as geographical altitude and type of unit will be collected.

Eligibility criteria:
inclusion criteria: intensivists who work in intensive care units localized above 1500 meters above sea level exclusion criteria: * fellows, retired members and pediatrics intensivists